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CLINICAL TRIALS PROFILE FOR HYLENEX RECOMBINANT

Clinical Trials for Hylenex Recombinant

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00311519	A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects	Completed	Halozyme Therapeutics	Phase 4	The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer’s is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.
NCT00435604	A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase	Completed	Halozyme Therapeutics	Phase 1	This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects. The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
NCT00477152	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	Halozyme Therapeutics	Phase 4	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	PPD	Phase 4	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	Baxter Healthcare Corporation	Phase 4	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00493220	Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration	Completed	Halozyme Therapeutics	Phase 1	The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
NCT00493220	Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration	Completed	Baxter Healthcare Corporation	Phase 1	The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
Trial ID	Title	Status	Sponsor	Phase	Summary